Efficacy of Bifeprunox in Patients With Schizophrenia

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Terminated

CT.gov ID

NCT00658645

Collaborator

(none)

227

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Bifeprunox Drug: Placebo Drug: Quetiapine	Phase 3

Detailed Description

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. In particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. In the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. Non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. The study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. After this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. In the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11916A).

Study Design

Study Type:

Interventional

Actual Enrollment :

227 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multinational, Randomised, Double-blind, Fixed-dose, Bifeprunox Study Combining a 12-Week Placebo-controlled, Quetiapine-referenced Phase With a 12-month Quetiapine-controlled Phase in Patients With Schizophrenia

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bifeprunox	Drug: Bifeprunox 20 mg daily, encapsulated tablets, orally, 12 months Other Names: DU 127090
Placebo Comparator: Placebo	Drug: Placebo Encapsulated tablets, orally, 12 weeks
Active Comparator: Quetiapine	Drug: Quetiapine 600 mg daily, encapsulated tablets, orally, 12 months Other Names: Seroquel

Arm

Intervention/Treatment

Experimental: Bifeprunox

Drug: Bifeprunox

20 mg daily, encapsulated tablets, orally, 12 months

Other Names:

DU 127090

Placebo Comparator: Placebo

Drug: Placebo

Encapsulated tablets, orally, 12 weeks

Active Comparator: Quetiapine

Drug: Quetiapine

600 mg daily, encapsulated tablets, orally, 12 months

Other Names:

Seroquel

Outcome Measures

Primary Outcome Measures

The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). [12 weeks]

Secondary Outcome Measures

The difference in PANSS score at the 12-month time point between bifeprunox and quetiapine. Also, responder rate, time to response/withdrawal, global clinical assessments (CGI), assessment of depressive symptoms (CDSS) and health economic assessments [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Main inclusion criteria

The subject has a primary diagnosis of schizophrenia
The subject experiences clinically significant symptoms
The subject's medication remained stable for 8 weeks prior to screening
The subject is currently in the post-acute maintenance phase of his/her disease

Exclusion Criteria:

Main exclusion criteria

The subject is at significant risk of suicide
The subject is treatment resistant
The subject has experienced an acute exacerbation within 8 weeks prior screening
The subject is unlikely to comply with the protocol
The subject has a current diagnosis or a history of substance abuse

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	BG002	Radnevo	Bulgaria	6260
2	BG003	Radnevo	Bulgaria	6260
3	CN009	Beijing	China	100083
4	CN008	Beijing	China	100088
5	GR001	Maroussi	Greece	15126
6	GR003	Tripoli	Greece	22100
7	RO004	Brasov	Romania	500123
8	RO001	Bucuresti	Romania	041914
9	RO002	Bucuresti	Romania	041914
10	RO003	Bucuresti	Romania	041914
11	RO009	Bucuresti	Romania	41914
12	RO008	Iasi	Romania	700265
13	RO005	Pitesti	Romania	110069
14	RO007	Sibiu	Romania	550082
15	RO006	Targoviste	Romania	130081
16	RU003	Arkhangelsk	Russian Federation	163060
17	RU017	Chita	Russian Federation	672090
18	RU001	Moscow	Russian Federation	115522
19	RU005	Moscow	Russian Federation	117152
20	RU002	Saratov	Russian Federation	410012
21	RU009	St. Petersburg	Russian Federation	190005
22	RU013	St. Petersburg	Russian Federation	190005
23	RU012	St. Petersburg	Russian Federation	190013
24	RU011	St. Petersburg	Russian Federation	191119
25	RU004	St. Petersburg	Russian Federation	193019
26	RU010	St. Petersburg	Russian Federation	193019
27	RU014	St. Petersburg	Russian Federation	193167
28	RU015	Tomsk	Russian Federation	634014
29	TW001	Hualien Town	Taiwan	970
30	TW003	Taipei	Taiwan	115
31	TH002	Bangkok	Thailand	10330
32	TH001	Bangkok	Thailand	10600
33	TH003	Chiang Mai	Thailand	50200
34	TH004	Chiang Mai	Thailand	50200
35	UA002	Glevakha	Ukraine	8630
36	UA001	Kyiv	Ukraine	02660
37	UA013	Kyiv	Ukraine	4655
38	UA012	Lugansk	Ukraine	91045